Regulatory Affairs Lead: Drug Registration & Compliance

Hammerjack Pty Ltd; Philippines; On-site; PHP 600,000 - 1,000,000; Full time

Job summary

Hammerjack Pty Ltd in the Philippines seeks a Regulatory Affairs Specialist to support registration, compliance, QA and Pharmacovigilance aligned with FDA requirements. The role covers dossier reviews, labeling, and lifecycle management across products.

You will prepare submissions, monitor regulatory commitments, and ensure timely reporting while coordinating with QA, PV, and cross-functional teams to uphold quality and compliance.

Qualifications

• Bachelor's or master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences; PRC license preferred.
• Minimum 3-5 years in PH Regulatory Affairs with end-to-end Drug Registration experience.
• Strong knowledge of ICH guidelines, CTD/eCTD, PIC/S GMP, WHO guidelines, and local regulatory frameworks.
• Excellent communication and stakeholder management skills.

Responsibilities

• Review regulatory dossiers and prepare product registration applications, including labeling materials.
• Support product lifecycle by maintaining regulatory dossiers and variations; monitor CPR validity and renewals.
• Prepare and monitor regulatory reports and documentation required by the FDA and other agencies.
• Serve as liaison with FDA and other authorities, coordinate responses to inquiries and inspections.
• Monitor Philippine FDA regulations and communicate changes to relevant departments.
• Oversee QA and Pharmacovigilance activities and coordinate with manufacturers and distributors.

Skills

Communication skills

Stakeholder management

Project coordination

Multicultural collaboration

Education

Bachelor's or Master's in Pharmacy/Pharmaceutical Sciences/Life Sciences

PRC license holder

Tools

RIMS/DMS/eCTD platforms

MS Office

Job description

Hammerjack Pty Ltd in the Philippines seeks a Regulatory Affairs Specialist to support registration, compliance, QA and Pharmacovigilance aligned with FDA requirements. The role covers dossier reviews, labeling, and lifecycle management across products.

You will prepare submissions, monitor regulatory commitments, and ensure timely reporting while coordinating with QA, PV, and cross-functional teams to uphold quality and compliance.